CN102078638A - Long-acting combination type wound dressing and preparation method thereof - Google Patents
Long-acting combination type wound dressing and preparation method thereof Download PDFInfo
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Abstract
The invention relates to long-acting combination type wound dressing and a preparation method thereof. The long-acting combination type wound dressing comprises chitosan, oligo-chitosan, chitosan oligosaccharide, glacial acetic acid, isinglass, glycerol and purified water, wherein 100 milliliters of purified water contains 0.5g-8g of isinglass, 0.5g-10g of oligo-chitosan, 0.5g-10g of chitosan oligosaccharide, 0.3g-6g of isinglass, 0.3 milliliters-6 milliliters of glacial acetic acid and 1 milliliters-10 milliliters of glycerol. The long-acting combination type wound dressing is novel bio-hydrogel dressing which is short in onset time and is long in action time, can promote the healing of burn and scald wounds and acute and chronic wounds, and has three functions of hemostasis, analgesia and healing promotion; three main raw materials with different molecular weight gradients, such as chitosan, oligo-chitosan and chitosan oligosaccharide, are used, so as to achieve the purpose that the main raw materials are gradually absorbed in turn and exerts actions.
Description
Technical field
The present invention relates to a kind of wound dressing and preparation method thereof, relate in particular to a kind of long-acting combined wound dressing and preparation method thereof.
Background technology
Chitosan be a kind of biopolymer that the chitin of one of organic resource the abundantest on the earth obtains through deacetylated reaction; its chemistry β by name-(1-4)-2-amino-2-deoxidation-D-glucosan; mainly process at present by ocean Prawn Eriocheir sinensis shell; as the total unique positively charged animal fiber that exists of nature; all attach great importance to the development and use of chitin and derivant thereof in recent years both at home and abroad, and find that it has a wide range of applications in field of medicaments.
Chitosan Oligosacchaides is that generally between 2000~10000, it has biodegradable to average molecular weight through a class oligosaccharide of chemical degradation or enzymolysis generation, and safety non-toxic has good biocompatibility and chemical stability.
Oligochitosan also is Chitosan oligosaccharide, formal name used at school β-1,4-oligosaccharide-glucamine, molecular weight is below 2000, being a kind of brand-new product that chitosan is obtained through special biological enzyme technology processing, is that water solublity is better, function is big, biological activity is high, absorbance is the low molecular weight product more than 80%.It has the unexistent higher solubility of chitosan and easily by the function of many uniquenesses such as organism absorption, and it act as 14 times of chitosan.Compare with chitosan, Chitosan Oligosacchaides, oligochitosan has higher biological activity, antibacterial, short more, hemostasis, improve immunity, suppress tumor cell, promote many-sides such as liver spleen antibody formation all to have a clear superiority in, also be widely used in medicine and field of functional food such as blood fat reducing, blood pressure lowering, blood sugar lowering, cholesterol regulating, fat-reducing, prevention adult disease.
Chitosan in use can be degraded to Chitosan Oligosacchaides, oligochitosan, monosaccharide successively by progressively degradeds such as the lysozyme of human body.Oligochitosan promote wound healing, hemostasis, antibacterial aspect effect particularly remarkable, but because degraded is very fast, can not bring into play dauer effect separately.
Chitosan is much used aspect wound care, but in present prior art, chitosan is used for wound care, short, all can not satisfy clinical demand well aspect product form, timeliness and the curative effect.Dressing is used for the technology that various burn and scald injure chronic wounds about chitosan gel rubber existing, exist with sheet-like hydrous gel dressing form, sponge dressing form or adhesive-bonded fabric dressing form mostly, such sheet-like hydrous gel dressing has that mechanical performance is too poor, comfortableness difference and breathability are poor, can not be applicable to shortcomings such as the irregular chamber of different shape hole wound surface and action effect persistency difference widely.Though the dressing of chitosan fluid has advantages such as excellent biological compatibility, good short more effect, exist also that degraded is slow, the performance effect takes the relatively shortcoming of length.
Summary of the invention
The present invention is directed to traditional single chitosan dressing onset time long, effect is not remarkable, and single oligochitosan action effect is obvious, but deficiencies such as degraded is fast, timeliness weak point, the overfrequency of changing dressings provide a kind of long-acting combined wound dressing and preparation method thereof.
The technical scheme that the present invention solves the problems of the technologies described above is as follows: a kind of long-acting combined wound dressing comprises chitosan, Chitosan Oligosacchaides, oligochitosan, glacial acetic acid, gelatin, glycerol and purified water, wherein, per 100 milliliters purified water contains the chitosan of 0.5 gram~8 grams, the Chitosan Oligosacchaides of 0.5 gram~10 grams, the oligochitosan of 0.5 gram~10 grams, the gelatin of 0.3 gram~6 grams, 0.3 milliliter~6 milliliters glacial acetic acid, 1 milliliter~10 milliliters glycerol.
The dosage form of employed raw material and invention product has determined the raw-material concentration proportioning scope of using among the present invention, and because of the chitosan molecule amount does not wait to millions of from tens thousand of, indexs such as the coefficient of kinetic viscosity of different medical gelatins also have certain difference.Molecular weight ranges that chitosan, Chitosan Oligosacchaides and oligochitosan are different and different deacetylations, the coefficient of kinetic viscosity that medical gelatin is different all can influence the physical indexs such as viscosity of product of the present invention.Reach requirements such as certain transparency, viscosity for meeting the invention product, the raw-material concentration proportioning of use is had the range of choice of broad.
The invention has the beneficial effects as follows: the long-acting combined wound dressing of the present invention is that a kind of onset time is short, long action time, passable promotion burn and scald, the acute and chronic wounds healing, and has hemostasis, analgesia and the short more new bio aerogel dressing of triple role, use the three kinds main raw material(s)s that are different molecular weight gradient are chitosan, Chitosan Oligosacchaides and oligochitosan, wherein the molecular weight of chitosan is about 100,000, molecular weight is excessive, intermolecular and intramolecular hydrogen bond makes strand twine severity each other, dissolubility is too small, molecular weight is low excessively, degraded is very fast, can not play the effect that product has dauer effect; The Chitosan Oligosacchaides molecular weight is between 2000~10000, and wherein molecular weight is 7000 for best, can either directly be dissolved in the water, and the time that plays a role of guaranteeing again to degrade is moderate; The oligochitosan molecular weight is for being lower than 2000.The composite use of these three kinds of materials mainly is applicable to chronic difficult healing of wound such as decubital ulcer, diabetic foot ulcer, lower limb vascular ulcer and I, II ° burn wound to reach by the purpose that progressively absorbs successively and play a role lastingly.
The present invention also provides a kind of technical scheme that solves the problems of the technologies described above as follows: a kind of preparation method of long-acting combined wound dressing may further comprise the steps:
1) in purified water, adds glacial acetic acid and make glacial acetic acid solution, in glacial acetic acid solution, add the liquid of making even clear after chitosan dissolves it fully again, wherein, per 100 milliliters interior glacial acetic acid and 0.5 that adds 0.3 milliliter~6 milliliters of purified water restrains~8 chitosans that restrain;
2) in the liquid of even clear, add gelatin, and place in 70 ℃~80 ℃ the water-bath and heat, dissolve fully to gelatin, wherein, add the gelatin of 0.3 gram~6 grams in per 100 milliliters purified water;
3) in the consoluet solution of gelatin, add Chitosan Oligosacchaides and oligochitosan, after being dissolved fully, it refilters the liquid of making even clear, wherein, per 100 milliliters interior Chitosan Oligosacchaides and 0.5 that add 0.5 gram~10 grams of purified water restrain~10 oligochitosans that restrain;
4) drip glycerol in the liquid of even clear, the PH of control solution is 4.5~6.5, stirs, and wherein, adds 0.1 milliliter~10 milliliters glycerol in per 100 milliliters purified water;
5) with gained solution filtering and impurity removing, carry out fill, sterilization after leaving standstill froth breaking, carry out sterility test again and get final product after qualified.
Further, add in the described step 1) to stir behind the chitosan it is dissolved fully, the speed of stirring is 65~296r/min.
Further, add in the described step 3) to stir behind Chitosan Oligosacchaides and the oligochitosan it is dissolved fully, the speed of stirring is 65~296r/min.
Further, add glycerol in the described step 4) after restir even, the speed of stirring is 65~296r/min.
Description of drawings
Fig. 1 is the effectiveness effect test figure of the embodiment of the invention 1 long-acting combined wound dressing;
Fig. 2 is the effectiveness effect test figure of the embodiment of the invention 2 long-acting combined wound dressings;
Fig. 3 is the effectiveness effect test figure of the embodiment of the invention 3 long-acting combined wound dressings;
Fig. 4 is the effectiveness effect test figure of the embodiment of the invention 4 long-acting combined wound dressings.
The specific embodiment
The following drawings is described principle of the present invention and feature, and institute gives an actual example and only is used to explain the present invention, is not to be used to limit scope of the present invention.
Embodiment 1: accurately take by weighing chitosan 0.5 gram and put in the agitator, add 100 milliliters of purified water, drip 0.4 milliliter of glacial acetic acid, stir evenly, mixing speed is 65r/min, to dissolving fully, becomes homogeneous solution.In this solution, add 6 gram gelatin, put on 75 ℃ the water-bath and heat, dissolve fully to gelatin, and then add 1.5 gram Chitosan Oligosacchaides and 10 gram oligochitosans and stir that to make its dissolving, mixing speed be 150r/min, add 1 milliliter of glycerol again, stir to dissolving fully, mixing speed is 100r/min, and control PH is 6.5, and is last, filtering and impurity removing, leave standstill bubble, the packing sterilization is finished product.
Embodiment 2: accurately take by weighing chitosan 2 grams and put in the agitator, add 100 milliliters of purified water, drip 1 milliliter of glacial acetic acid, stir evenly, mixing speed is 150r/min, to dissolving fully, becomes homogeneous solution.In this solution, add 4 gram gelatin, put on 75 ℃ the water-bath and heat, dissolve fully to gelatin, and then add 4 gram Chitosan Oligosacchaides and 6 gram oligochitosans and stir that to make its dissolving, mixing speed be 150r/min, add 4 milliliters of glycerol again, stir to dissolving fully, mixing speed is 100r/min, and control PH is 5.5, and is last, filtering and impurity removing, leave standstill bubble, the packing sterilization is finished product.
Embodiment 3: accurately take by weighing chitosan 4 grams and put in the agitator, add 100 milliliters of purified water, drip 3 milliliters of glacial acetic acid, stir evenly, mixing speed is 200r/min, to dissolving fully, becomes homogeneous solution.In this solution, add 2 gram gelatin, put on 75 ℃ the water-bath and heat, dissolve fully to gelatin, and then add 6 gram Chitosan Oligosacchaides and 2 gram oligochitosans and stir that to make its dissolving, mixing speed be 150r/min, add 6 milliliters of glycerol again, stir to dissolving fully, mixing speed is 100r/min, and control PH is 5, and is last, filtering and impurity removing, leave standstill bubble, the packing sterilization is finished product.
Embodiment 4: accurately take by weighing chitosan 8 grams and put in the agitator, add 100 milliliters of purified water, drip 6 milliliters of glacial acetic acid, stir evenly, mixing speed is 295r/min, to dissolving fully, becomes homogeneous solution.In this solution, add 0.5 gram gelatin, put on 80 ℃ the water-bath and heat, dissolve fully to gelatin, and then add 0.5 gram Chitosan Oligosacchaides and 0.5 gram oligochitosan and stir that to make its dissolving, mixing speed be 150r/min, add 10 milliliters of glycerol again, stir to dissolving fully, mixing speed is 80r/min, and control PH is 4.5, and is last, filtering and impurity removing, leave standstill bubble, the packing sterilization is finished product.
Involved raw and auxiliary material in the foregoing description, be medical grade material, wherein chitosan, Chitosan Oligosacchaides and oligochitosan are the medical grade products that the ten thousand sharp medical products company limited independent researches of Yantai, Shandong are produced, the composition of this medical grade products and performance are the same with commercially available chitosan, Chitosan Oligosacchaides and oligochitosan, so chitosan, Chitosan Oligosacchaides and the oligochitosan that also can adopt commercially available condition to conform to; Gelatin is the medical grade gelatin that Daan City, Jilin Province sieve celo gelatin company limited is produced; Glycerol and acetic acid are and meet officinal medical grade material.
Through the effectiveness effect test of Experiment of Zoology rat diabetic foot chronic ulcer model, the result shows: (the accurate word Z12020440 of traditional Chinese medicines) compares with the positive reference substance JINGWANHONG, and its effect is equal to or is better than positive controls, obviously is better than the blank group.
As shown in Figure 1, at embodiment 1 from hinder the back the 2nd day, the average healing rate of experimental group is 21.98472, the average healing rate of positive controls is 13.96351, the average healing rate of blank group is 6.77684, experimental group is significantly greater than positive controls (P<0.05), and experimental group and positive controls are all significantly greater than blank group (P<0.05); Time the 8th day, the average healing rate of experimental group is 55.94379, and the average healing rate of positive controls is 51.97882, between the two there was no significant difference (P is greater than 0.05).Short more effect more as shown in the figure.
As shown in Figure 2, at embodiment 2, experimental group healing rate and positive controls healing rate there was no significant difference, but all significantly greater than the blank group.Short more effect more as shown in the figure.
As shown in Figure 3, from hindering the back the 7th day, the experimental group healing rate is significantly greater than positive controls healing rate (P<0.05) at embodiment 3.All there are significant difference relation (P<0.05) in experimental group and positive controls and experimental group and blank group.Short more effect more as shown in the figure.
As shown in Figure 4, at embodiment 4 from hinder the back the 2nd day, the average healing rate of experimental group is 13.96375, the average healing rate of positive controls is 13.56321, the average healing rate of blank group is 6.97689, experimental group and positive controls there was no significant difference (P>0.05), experimental group healing rate are significantly greater than the healing rate (P<0.05) of blank group; Time the 6th day, the average healing rate of experimental group is 45.98807, the average healing rate of positive controls is 35.54782, and the average healing rate of blank group is 23.17244, and all there are significant difference relation (P<0.05) in experimental group and positive controls and experimental group and blank group.Short more effect more as shown in the figure.
The long-acting combined wound dressing of the present invention has following beneficial effect and is: 1. onset time fast, can effectively promote the healing of wound fast; It is 2. short that more effect is lasting, long-acting, remarkable; 3, has effective anastalsis; 4, has effective analgesic activity; 5, resistance bacterium, bactericidal antiphlogistic function; 6, have film property, can effectively absorb wound fluid, prevent the infiltration of transudate, play wound obstruct, protective effect simultaneously wound; 7, have comfortableness, simple and practical, have no side effect.
It is a kind of new bio functional dressings that primary raw material is succeeded in developing that the long-acting combined wound dressing of the present invention adopts chitosan, Chitosan Oligosacchaides and the oligochitosan of taking from natural marine organism shrimp Eriocheir sinensis shell, it is the new pattern compress of primary raw material that research report chitosan and derivant are arranged, when reducing dressing change frequency and step again, help the healing of ulcer surface, reduce the working procedure of nursing, increase work efficiency, save patient's hospitalization cost etc., these advantages are that chitosan product treatment chronic wounds has been opened up new road; Through toxicology test, zoology test, bacteriostatic test and clinical examination, prove that this product is nontoxic, harmless, non-stimulated, no sensitization, biomaterial safely and reliably.
Biological property indexs such as new bio dressing of the present invention is aseptic by controlling, cell toxicity test, sensitization, haemolysis, skin irritation are to guarantee the clinical safe in utilization of product; PH value by the control product: 4.5~6.5, can wound or skin not produced stimulation to guarantee product, can keep little acid environment of wound surface again, better promote the healing of wound face; Because of product of the present invention is employed is molecular weight chitosan, Chitosan Oligosacchaides and oligochitosan biomaterial in gradient, also oligochitosan when playing a role from small-molecular weight, effect one by one and that can bring into play the promotion healing fast, so it has good, persistent, as to promote healing effect to acute and chronic wound, burn and scald, also have hemostasis to wound, analgesia, antibacterial and reduce the effect of cicatrization simultaneously.This invention product can form the thin film of layer of transparent after drying is used in the part simultaneously, plays aseptic natural cover for defense effect.Product of the present invention to the healing time of wound than the remarkable shortening of conventional medicine, easy to use, be subjected to clinical welcome deeply.
The above only is preferred embodiment of the present invention, and is in order to restriction the present invention, within the spirit and principles in the present invention not all, any modification of being done, is equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (5)
1. long-acting combined wound dressing, it is characterized in that, described wound dressing comprises chitosan, Chitosan Oligosacchaides, oligochitosan, glacial acetic acid, gelatin, glycerol and purified water, wherein, per 100 milliliters purified water contains the chitosan of 0.5 gram~8 grams, the Chitosan Oligosacchaides of 0.5 gram~10 grams, the oligochitosan of 0.5 gram~10 grams, the gelatin of 0.3 gram~6 grams, 0.3 milliliter~6 milliliters glacial acetic acid, 1 milliliter~10 milliliters glycerol.
2. the preparation method of a long-acting combined wound dressing is characterized in that, described preparation method may further comprise the steps:
1) in purified water, adds glacial acetic acid and make glacial acetic acid solution, in glacial acetic acid solution, add the liquid of making even clear after chitosan dissolves it fully again, wherein, per 100 milliliters interior glacial acetic acid and 0.5 that adds 0.3 milliliter~6 milliliters of purified water restrains~8 chitosans that restrain;
2) in the liquid of even clear, add gelatin, and place in 70 ℃~80 ℃ the water-bath and heat, dissolve fully to gelatin, wherein, add the gelatin of 0.3 gram~6 grams in per 100 milliliters purified water;
3) in the consoluet solution of gelatin, add Chitosan Oligosacchaides and oligochitosan, after being dissolved fully, it refilters the liquid of making even clear, wherein, per 100 milliliters interior Chitosan Oligosacchaides and 0.5 that add 0.5 gram~10 grams of purified water restrain~10 oligochitosans that restrain;
4) drip glycerol in the liquid of even clear, the PH of control solution is 4.5~6.5, stirs, and wherein, adds 1 milliliter~10 milliliters glycerol in per 100 milliliters purified water;
5) with gained solution filtering and impurity removing, carry out fill, sterilization after leaving standstill froth breaking, carry out sterility test again and get final product after qualified.
3. the preparation method of long-acting combined wound dressing according to claim 2 is characterized in that, stirs behind the adding chitosan in the described step 1) it is dissolved fully, and the speed of stirring is 65~296r/min.
4. the preparation method of long-acting combined wound dressing according to claim 2 is characterized in that, stirs behind adding Chitosan Oligosacchaides and the oligochitosan in the described step 3) it is dissolved fully, and the speed of stirring is 65~296r/min.
5. the preparation method of long-acting combined wound dressing according to claim 2 is characterized in that, add glycerol in the described step 4) after restir even, the speed of stirring is 65~296r/min.
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CN103083712A (en) * | 2011-11-01 | 2013-05-08 | 北京清美联创干细胞科技有限公司 | Stem cells or other bioactive substances doped surgical dressing |
CN105106292A (en) * | 2015-09-11 | 2015-12-02 | 任汉学 | Polysaccharide biomedical colloidal fluid and preparation method |
CN106215221A (en) * | 2016-08-30 | 2016-12-14 | 上海昊海生物科技股份有限公司 | Oligochitosan gelatin akermanite nanofiber biological dressing and preparation method thereof |
CN106693029A (en) * | 2015-08-24 | 2017-05-24 | 中国科学院金属研究所 | Preparation method of chitosan oligosaccharide -based polyelectrolyte styptic powder |
CN106963977A (en) * | 2017-05-26 | 2017-07-21 | 广东海洋大学 | A kind of Breviscapinun/chitosan composite aquogel for suppressing cicatrization and preparation method thereof |
CN107185031A (en) * | 2017-05-23 | 2017-09-22 | 广州润虹医药科技有限公司 | A kind of medical dressing with bioactivity and preparation method thereof |
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CN101879324A (en) * | 2010-07-02 | 2010-11-10 | 西南大学 | Method for preparing chitosan-based composite dressing for medical use |
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CN101791425A (en) * | 2010-03-30 | 2010-08-04 | 赵雪林 | Antibacterial heal-promoting gel material used for preparing medical wound dressing and preparation method thereof |
CN101879324A (en) * | 2010-07-02 | 2010-11-10 | 西南大学 | Method for preparing chitosan-based composite dressing for medical use |
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CN106693029A (en) * | 2015-08-24 | 2017-05-24 | 中国科学院金属研究所 | Preparation method of chitosan oligosaccharide -based polyelectrolyte styptic powder |
CN105106292A (en) * | 2015-09-11 | 2015-12-02 | 任汉学 | Polysaccharide biomedical colloidal fluid and preparation method |
CN106215221A (en) * | 2016-08-30 | 2016-12-14 | 上海昊海生物科技股份有限公司 | Oligochitosan gelatin akermanite nanofiber biological dressing and preparation method thereof |
CN108721678A (en) * | 2017-04-20 | 2018-11-02 | 许盈 | A kind of bandage and preparation method thereof |
CN107185031A (en) * | 2017-05-23 | 2017-09-22 | 广州润虹医药科技有限公司 | A kind of medical dressing with bioactivity and preparation method thereof |
CN106963977A (en) * | 2017-05-26 | 2017-07-21 | 广东海洋大学 | A kind of Breviscapinun/chitosan composite aquogel for suppressing cicatrization and preparation method thereof |
CN106963977B (en) * | 2017-05-26 | 2018-03-30 | 广东海洋大学 | A kind of Breviscapinun/chitosan composite aquogel for suppressing cicatrization and preparation method thereof |
CN109529099A (en) * | 2018-11-27 | 2019-03-29 | 浙江海洋大学 | A kind of dual network loading chitosan enzyme aerogel dressing and preparation method thereof based on three-dimensional printing technology |
CN109481148A (en) * | 2018-12-24 | 2019-03-19 | 苏州榭睿迦医疗科技发展有限公司 | A kind of moisture absorption vapor-permeable type wound dressing patch |
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CN110193022A (en) * | 2019-06-04 | 2019-09-03 | 湖北中医药大学 | Application of the chitosan oligosaccharide in terms of improving lower limb ischemia caused by a variety of diseases |
CN110193022B (en) * | 2019-06-04 | 2022-10-11 | 湖北中医药大学 | Application of chitosan oligosaccharide in improving lower limb ischemia caused by various diseases |
CN112876696A (en) * | 2021-01-18 | 2021-06-01 | 无锡市第二人民医院 | Biomedical polyglyceryl hydrogel and preparation method thereof |
CN112876696B (en) * | 2021-01-18 | 2021-10-29 | 无锡市第二人民医院 | Biomedical polyglyceryl hydrogel and preparation method thereof |
CN113713164A (en) * | 2021-09-03 | 2021-11-30 | 军事科学院系统工程研究院卫勤保障技术研究所 | Preparation method of chitosan polymer dressing and product |
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Application publication date: 20110601 |